Health Condition 1: null- acute Lumbago, acute Integumental and acute Musculoskeletal pain
Conditions
Interventions
Intervention1: Phenyramidol: Tablet
Control Intervention1: NIL: NIL
Sponsors
Fermenta Biotech Limited
Eligibility
Inclusion criteria
Inclusion criteria: i) Patients suffering from acute Lumbago, acute Integumental and acute Musculoskeletal pain. ii) Patients of either sex between 18 to 60 years of age. iii) Patients who are willing to take the medications as directed and willing to come for follow-ups. iv) Patients who comply with the protocol requirements. v) Patients who give the written informed consent. vi) Patients or their representative capable of making entry in Patient Diary Card.
Exclusion criteria
Exclusion criteria: i) Patients with hypersensitivity to any of the ingredients of the investigational product. ii) Patients already on analgesics, muscle relaxants, and tranquilizers 24 hours before first dose of investigational drug. iii) Pregnant/lactating women. iv) Women of child bearing potential who do not agree to remain abstinent or use medically acceptable methods of contraception and 2 weeks following the end of the study therapy. v) Patients unavailable on phone for follow-up. vi) Any specific condition which does not justify patient?s inclusion in the study in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety endpoints will be analyzed using the safety population, consisting of all patients who have taken at least one dose of the study medication. Analysis of demographic and baseline characteristics.Timepoint: day one, day seven, day fourteen | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy:- Mean change in pain intensity (as indicated by patient?s self rated assessment on 10 point NPRS,) from baseline (before dose 1) to end of therapy.Timepoint: day one, day seven, day fourteen | — |
Countries
India
Contacts
Public ContactSophia Lily
Outcome results
None listed